Flexible endoluminal device

ABSTRACT

The present disclosure describes endoluminal devices, such as stents and stent grafts capable of being bent smoothly, with various benefits resulting therefrom.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/079,353, filed Nov. 13, 2013, entitled FLEXIBLE ENDOLUMINAL DEVICE,which claims the benefit of U.S. Provisional Application 61/727,585,filed Nov. 16, 2012, entitled FLEXIBLE ENDOLUMINAL DEVICE, both of whichare incorporated herein by reference in their entireties for allpurposes.

FIELD

The present disclosure relates generally to endoluminal devices and,more specifically, to endoluminal devices such as stents and stentgrafts capable of being bent smoothly.

BACKGROUND

Endoluminal devices such as stents, stent grafts, catheters, filters,valves, anchors, occluders, and other implantable devices are frequentlyused to treat the vasculature of mammalian patients. Such devices ofteninclude a frame comprising a stent which may be used alone or inconnection with other materials such as graft or filtering materials. Itmay be desirable that the stent be capable of flexing as it is bentwithin the vasculature and thus, bend smoothly without producing a kink.For example, it may be desirable that the stent be capable of nesting asit is bent within the vasculature and thus, bend smoothly. Thus, thereis a need for stents that provide such characteristics.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure,and together with the description serve to explain the principles of thedisclosure, wherein:

FIG. 1A illustrates a side view of a stent in accordance with thepresent disclosure;

FIG. 1B illustrates a side view of a stent graft in accordance with thepresent disclosure;

FIG. 2A illustrates a close-up view of circumferentially uniform nestedrings in accordance with the present disclosure;

FIG. 2B illustrates a close-up view of circumferentially non-uniformnested rings in accordance with the present disclosure;

FIG. 3A illustrates a side view of a stent graft comprised of ringshaving different diameters in accordance with the present disclosure;

FIG. 3B illustrates a side view of a stent graft comprised of ringshaving the same diameter in accordance with the present disclosure;

FIG. 4A illustrates a close-up side view of adjacent nested rings havingthe same profile in accordance with the present disclosure; and

FIG. 4B illustrates a close-up side view of adjacent nested rings havingalternating profiles in accordance with the present disclosure.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andsystems configured to perform the intended functions. Stateddifferently, other methods and systems can be incorporated herein toperform the intended functions. It should also be noted that theaccompanying drawing figures referred to herein are not all drawn toscale, but may be exaggerated to illustrate various aspects of thepresent disclosure, and in that regard, the drawing figures should notbe construed as limiting. Finally, although the present disclosure canbe described in connection with various principles and beliefs, thepresent disclosure should not be bound by theory.

Endoluminal devices such as stents, stent grafts, catheters, filters,valves, anchors, occluders, and other implantable devices are frequentlyused to treat the vasculature of mammalian patients. Such devices ofteninclude a frame comprising a stent which may be used alone or inconnection with other materials such as graft or filtering materials.

With reference to FIGS. 1A and 1B, a stent 100 is a generally tube likestructure that defines a lumen and that is inserted into the vasculatureto open and/or maintain the vasculature in order to prevent or addresslocalized flow constriction, weakening of the vasculature wall,aneurisms, etc. In this regard, the stent 100 can be comprised of aplurality of hoops (e.g., as illustrated in FIG. 1A), can have a helicalconfiguration (e.g., as illustrated in FIG. 1B), can be cut from a tube,etc.

As used herein, a ring 110A,B of the stent 100 is a longitudinal sectionthereof which can comprise one or more hoops 120, helical windings 130,etc. For instance, a ring 110A may broadly comprise a single hoop 120 ortwo or more hoops 120A,B. Likewise, a ring 110B may broadly comprise asingle helical winding 130 or two or more helical windings (not shown).Hoops 120 and helical windings 130 may include various further patternsalong their length such as undulating patterns with angular apical areasinterconnected by generally straight sections, zig-zag patterns, diamondpatterns, etc. As used herein in relation to a stent, luminal refers toan interior of a stent, while abluminal refers to an exterior of astent.

In some embodiments, the stent 100 is comprised of a shape-memorymaterial, such as, but not limited to, nitinol. In other embodiments,the stent 100 can be compressible. In yet other embodiments, the stent100 can be comprised of other materials, self-expandable or otherwiseexpandable (e.g., with a balloon or spring mechanism), such as variousmetals (e.g., stainless steel), alloys and polymers.

Adjacent rings of the stent 100 (including individual hoops 120 andhelical windings 130) can be coupled with one or more interconnections150A,B, which can be comprised of various materials now known or as yetunknown. For example, such interconnection materials can comprise anynumber of biocompatible materials, such as, for example, expandedpolytetrafluoroethylene (ePTFE), expanded modified PTFE, and expandedcopolymers of PTFE, fluorinated ethylene propylene (FEP), polyester,polyurethane, fluoropolymers, such as perfouorelastomers and the like,polytetrafluoroethylene, silicones, urethanes, ultra high molecularweight polyethylene, aramid fibers, other polymeric materials, andcombinations thereof.

The interconnections 150A,B can be in contact with an abluminal and/orluminal surface of the stent 100. The interconnection 150B can cover allor a substantial portion of a longitudinal surface of the stent 100(e.g., in connection with an endoluminal graft as illustrated in FIG. 1Bor an endoluminal filter). In alternate embodiments, one or more of theinterconnections 150A can couple adjacent rings 110A of the stent 100 atone or more discrete locations (e.g., in connection with the stent 100as illustrated in FIG. 1A). In this regard, adjacent rings of the stent100 coupled with one or more of the interconnections 150A,B can be usedin connection with a wide variety of endoluminal devices such as stentgrafts, catheters, filters, valves, anchors, occluders, and otherimplantable devices.

In various embodiments, and with reference to FIGS. 2A and 2B, a stent200 is capable of nesting as it is bent within the vasculature, whichmay in turn facilitate smooth bending of the stent 200.

The terms “smooth” and “smoothly” as used herein in relation to thebending of an endoluminal device or a stent refers to a change inluminal direction while substantially maintaining the patency of thelumen, for example, without kinking the lumen.

As used herein, nesting refers to the relative movement of a ring 210Aof the stent 200 with respect to an adjacent ring 210B of the stent 200in a telescoping fashion, whereupon at least a portion of an abluminalsurface 202 of the ring 210A of the stent 200 faces at least a portionof a luminal surface 204 of the adjacent ring 210B of the stent 200. Invarious embodiments, the ring 210B luminal surface at least partiallysurrounds the adjacent ring 210A abluminal surface. In variousembodiments, the adjacent rings 210A,B are concentric one with another.In other embodiments, the adjacent rings 210A,B are nonconcentric onewith another.

In various embodiments, as illustrated in FIG. 2A, the stent 200 iscapable of nesting circumferentially. In various embodiments, asillustrated in FIG. 2B, the stent 200 is capable of nesting in acircumferentially non-uniform manner so as to facilitate bending withinthe vasculature. For example, the stent 200 can nest only along alongitudinal portion thereof that is intended to be oriented on an innercurve within the vasculature. Moreover, the stent 200 can nestdifferently along its length. For example, it may be desirable for afirst portion of the stent 200 to facilitate bending in a firstdirection, and a second portion of the stent 200 to either facilitatebending in a second direction or remain rigid and not facilitatebending.

Various approaches to nesting are contemplated by the presentdisclosure, each of which may be used alone or in combination. Invarious embodiments, adjacent rings 310A,B of a stent 300 can havedifferent diameters, for example, as illustrated in FIG. 3A (refer alsoto FIG. 1B). More specifically, the ring 310A inner diameter can begreater than the adjacent ring 310B outer diameter. In variousembodiments, the ring 310A outer diameter can be less than the adjacentring 310B inner diameter. The difference between the ring 310A outerdiameter and the adjacent ring 310B inner diameter can vary based onstent-graft diameter, wire diameter, graft wall thickness, etc. Inembodiments wherein the stent 300 is comprised of a plurality of hoops,one or more adjacent hoops can differ in diameter. In other embodimentswherein the stent 300 has a helical configuration, one or more adjacenthelical windings can differ in diameter.

In various embodiments, the ring 310A inner diameter at an edge isgreater than the adjacent ring 310B outer diameter at an adjacent edge,while the dimensions of adjacent rings 310A,B of the stent 300 can varyaway from their respective edges. For example, and with momentaryreference to FIG. 4A, adjacent rings 410A,B,C of a stent 400A can havethe same profile and have a larger diameter at one end than another, tothereby facilitate nesting of adjacent rings 410A,B,C. In otherembodiments, and with momentary reference now to FIG. 4B, adjacent rings410D,E,F of a stent 400B can have different profiles and alternatebetween having a larger diameter at the ends and having a larger in themiddle, to thereby facilitate nesting of adjacent rings 410D,E,F. Itshould be understood that the foregoing are mere examples and should notbe construed as limiting the various configurations of adjacent edgeshaving different diameters contemplated by the present disclosure.

In various embodiments, nesting can be enabled by adjacent rings 310C,Dof a stent 300 having the same diameter, for example, as illustrated inFIG. 3B (refer also to FIG. 1A), but different radial strength.Different radial strength can in turn be achieved, inter alia, by theadjacent rings 310C,D having different material properties and/ordifferent non-diameter dimensional characteristics (e.g., differentcross-sections), or by manipulating one or more interconnections betweenthe adjacent rings 310C,D. By way of non-limiting example, the adjacentrings 310C,D of the stent 300 may be partially or fully taped by one ormore interconnections to thereby couple the adjacent rings 310C,D and/orrender them (or one or both of their respective edges) with differentradial strength.

In connection with any of the foregoing embodiments, nesting of adjacentrings can be enhanced by incorporating an interconnection in contactwith both a ring abluminal surface and an adjacent ring luminal surface,which may assist the ring in “diving” under the adjacent ring to nesttherewith. Such an interconnection can be comprised of one or morepolymeric materials having resilient properties.

In various embodiments, the materials and components of the stents andinterconnections in accordance with the present disclosure can alsoinclude one or more bioactive agents. For example, the materials orcomponents can be coated by a therapeutic agent such as, for example,heparin, sirolimus, paclitaxel, everolimus, ABT-578, mycophenolic acid,tacrolimus, estradiol, oxygen free radical scavenger, biolimus A9,anti-CD34 antibodies, PDGF receptor blockers, MMP-1 receptor blockers,VEGF, G-CSF, HMG-CoA reductase inhibitors, stimulators of iNOS and eNOS,ACE inhibitors, ARBs, doxycycline, thalidomide, and many others.

Moreover, the materials and components of the stents andinterconnections in accordance with the present disclosure can comprisea radio-opaque or echogenic element that enhances imaging or detectionduring and/or following delivery or deployment. Radio-opaque markers orbands can be comprised of one or more of tungsten, gold, platinum andthe like.

The present disclosure also relates to methods of using flexibleendoluminal devices capable of bending smoothly. In accordance withvarious embodiments, an implantable device comprising a stent isrestrained or otherwise covered in a radially collapsed deliveryconfiguration by a releasable or removable cover such as a sleeve,sheath, sock or other constraining mechanism. The implantable device isinserted into the vasculature and delivered to a treatment site where itis deployed and assumes a radially expanded configuration. The stentelement of the implantable device can be bent smoothly in accordancewith the various nesting approaches described supra.

An example of a flexible stent graft was made in the following way: Twosets of NiTi 0.3 mm diameter wire were made by winding 0.3 mm diameterwire in a zig-zag pattern over two stainless steel mandrels 10 mm and 11mm in diameter respectively. The mandrels with the rings were heated ina convection air oven for 15 minutes at the temperature of 475 degreesCelsius. After the heating, the rings were quenched in a cold water bathto have their shape set at 10 mm and 11 mm inner diameter.

A thin wall ePTFE tube was pulled over an 11 mm diameter stainless steeltubing mandrel. The NiTi rings were placed on top of the ePTFE tubingover the mandrel in an altering fashion—a smaller diameter ring followedby a larger diameter ring in a repetitive way. The 10 mm rings had to beover expended to fit over the mandrel.

The rings were spaced approximately 1 mm apart one from another. Next,the rings were taped with ePTFE film that had FEP on one side. Topromote bonding between the rings, the tube and the tape, a compressionoverwrap was applied.

The assembly was placed in a convection air oven for 30 minutes at thetemperature of 320 degrees Celsius. After cooling down the externaloverwrap was taken off and the device was removed off the mandrel. Thesmaller 10 mm diameter rings that were overextended while being placedon the 11 mm diameter now returned to their nominal size of 10 mm thuscreating alternating smaller and larger segments of the device. Thedevice resulted to be very flexible without tendency to kinking due tonesting of the smaller segments into the larger segments.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present disclosurewithout departing from the spirit or scope of the disclosure. Forexample, stents having non-circular cross sections are contemplated bythe present disclosure. Thus, it is intended that the present disclosurecover the modifications and variations of this disclosure provided theycome within the scope of the appended claims and their equivalents.

Likewise, numerous characteristics and advantages have been set forth inthe preceding description, including various alternatives together withdetails of the structure and function of the devices and/or methods. Thedisclosure is intended as illustrative only and as such is not intendedto be exhaustive. It will be evident to those skilled in the art thatvarious modifications may be made, especially in matters of structure,materials, elements, components, shape, size and arrangement of partsincluding combinations within the principles of the invention, to thefull extent indicated by the broad, general meaning of the terms inwhich the appended claims are expressed. To the extent that thesevarious modifications do not depart from the spirit and scope of theappended claims, they are intended to be encompassed therein.

What is claimed is:
 1. An implantable device comprising: a first ringhaving a first ring radial strength; a second ring having a second ringradial strength; and an interconnection coupling the first ring and thesecond ring, the interconnection covering at least a portion of theimplantable device; wherein the first ring is adjacent to the secondring, the adjacent first and second rings having the same diameter andthe first ring radial strength being less than the second ring radialstrength, such that the first ring is configured to nest with the secondring.
 2. The implantable device of claim 1, wherein the interconnectioncomprises a fluoropolymer.
 3. The implantable device of claim 2, whereinthe first ring is partially taped with the interconnection.
 4. Theimplantable device of claim 2, wherein the second ring is fully tapedwith the interconnection.
 5. The implantable device of claim 1, whereinthe first ring and the second ring have different material properties.6. The implantable device of claim 1, wherein the first ring and thesecond ring have different non-diameter dimensional characteristics. 7.The implantable device of claim 1, wherein the interconnection is incontact with a ring abluminal surface and an adjacent ring luminalsurface.
 8. The implantable device of claim 1, wherein the implantabledevice is selected from a group consisting of a stent and a stent-graft.9. The implantable device of claim 1, wherein the interconnection isdefined by at least a portion of a cover member.
 10. An implantabledevice comprising: a first ring having a first ring radial strength; asecond ring having a second ring radial strength; and an interconnectioncoupling the first ring and the second ring, the interconnection definedby at least a portion of a cover member; wherein the first ring isadjacent to the second ring, the adjacent first and second rings havingthe same diameter and the first ring radial strength being less than thesecond ring radial strength, such that the first ring is configured tonest with the second ring.
 11. An implantable device comprising: a firstring having a first ring radial strength; a second ring having a secondring radial strength; and an interconnection coupling the first ring andthe second ring, the interconnection comprising a fluoropolymer and thefirst ring partially taped with the interconnection; wherein the firstring is adjacent to the second ring, the adjacent first and second ringshaving the same diameter and the first ring radial strength being lessthan the second ring radial strength, such that the first ring isconfigured to nest with the second ring.
 12. An implantable devicecomprising: a first ring having a first radial strength; a second ringhaving a second ring radial strength; and an interconnection couplingthe first ring and the second ring, the interconnection comprising afluoropolymer and the second ring fully taped with the interconnection;wherein the first ring is adjacent to the second ring, the adjacentfirst and second rings having the same diameter and the first ringradial strength being less than the second ring radial strength, suchthat the first ring is configured to nest with the second ring.
 13. Animplantable device comprising: a first ring having a first ring radialstrength; a second ring having a second ring radial strength; and aninterconnection coupling the first ring and the second ring, theinterconnection in contact with a ring abluminal surface and an adjacentring luminal surface; wherein the first ring is adjacent to the secondring, the adjacent first and second rings having the same diameter andthe first ring radial strength being less than the second ring radialstrength, such that the first ring is configured to nest with the secondring.